Assistant Director Clinical Scientist, Oncology Job at Medical Scientist at SanofiLocation Cambridge, Massachusetts Job Category Medical Scientist Requisition Number 00270998-56989
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health. Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company that is dedicated to improving health and driving back disease by making innovative medicines accessible to people around the world.
Our extensive research and development efforts encompass a wide range of therapeutic areas that are in line with public health issues, trends and the most pressing health needs.
Sanofi US, along with the other US affiliates, Genzyme, Sanofi Pasteur, Merial and Chattem, employs more than 17,000 people across the country.
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Job Title: Clinical Scientist (SAR650984)
This individual contributes to the worldwide Clinical Development of SAR650984 for Myeloma and Hematology indications and ensures clinical support to the project for optimal clinical development. This position reports directly into the project physician and will interface directly with the medical, writing, and operational functions.
·Contribute to (assist the clinical lead in) the clinical development plans in collaboration with the project MD including evaluation of translational medicine and biomarker strategy, discussions with clinical investigators and advisors and contingency planning
·Help author and review protocol and study design, amendments, IB, clinical sections of IND/IMPD and CTAs fillings, annual reports, clinical study reports, and risk-management plans, and regulatory documents (INDs, NDAs) under the guide of the project physician
oClosely liaise with operational group to ensure study design feasibility
oSeek collaboration/input from key line functions
oAssist in preparation of regulatory responses
·Identify core competencies of potential study sites for all phases of oncology trials from a scientific/strategic perspective (distinct from the evaluation given by clinical operations)
·Assist in the conduct of study site initiation visits (preparation, personnel training, etc.) and study start-up + close-up meetings, global investigator meetings (preparation of the scientific and medical communication).
·Present and discuss project and study strategy with key internal stakeholders, KOLs, advisory boards
·Assist study physician with review of the safety and efficacy data (“DDR”, PV, coding when appropriate)
·Provide operational oversight for:
oClinical data review and interpretation
oStudy manual/study tools
·Routinely interface with discovery, safety sciences, statistics, PK, pharmacovigilance (e.g. SAEs and narratives), regulatory, health economic (studies, planning, questionnaires administration), development operations and clinical operations and other members of the extended project team to deliver studies on time and within budget
·Author and review clinical abstracts, presentations for conferences when appropriate and assist with writing and managing manuscripts for completed studies.
·Provide feedback to the team with data from the clinical study (contribute to discussions regarding adjustments in the study and/or strategy based on the data)
·Demonstrated ability to work a global product with key functional groups in a matrix environment
·Comfortable with the review of medical clinical data. Prior responsibility for creating and driving a clinical analysis plan
·Familiar with phases of clinical research on a global basis- preferably pivotal and Phase III trials
·Strong organizational skills
·Attention to detail
·Excellent communication skills – oral and written
· A Ph.D. in a related field or Pharm.D required
· Minimum of 5 years of post-graduate experience, of which at least 3 years include direct involvement with clinical research
· Experience developing strong networks internally and externally beyond initial field of expertise
· Malignant hematology experience is preferred
Job : R&D Program Management
Primary Location : United States-Massachusetts-Cambridge (U.S.)
Job Posting : Sep 20, 2016, 1:46:11 PM
Job Type : Regular
Employee Status : Regular